Cytokinetics NDA for Omecamtiv Mecarbil Accepted By FDA

 Cytokinetics Inc. said the U.S. Food & Drug Administration has accepted and filed a new drug application for omecamtiv mecarbil, an investigational small molecule cardiac myosin activator, for the treatment of heart failure with reduced ejection fraction.

The company said the FDA assigned the NDA a standard review with a Prescription Drug User Fee Act target action date of Nov. 30, 2022. The FDA indicated it isn't planning to hold an advisory committee meeting to discuss the application.

The company said the NDA is supported by the results from a Phase 3 cardiovascular clinical trial of omecamtiv mecarbil that enrolled more than 8,000 patients in 35 countries across 945 sites. The trial demonstrated a statistically significant effect of treatment with omecamtiv mecarbil to reduce risk of the primary composite endpoint of cardiovascular death or heart failure events compared to placebo in patients treated with standard of care.

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